EC approves Cabotegravir LA by ViiV Healthcare for HIV prevention

EC approves Cabotegravir LA by ViiV Healthcare for HIV prevention

ViiV Healthcare, majorly owned by GSK with Pfizer and Shionogi as shareholders, announced that the European Commission (EC) has authorized Apretude, also known as cabotegravir long-acting (LA) injectable and tablets, for HIV prevention. This revolutionary treatment is now the only approved HIV prevention option in the European Union that offers an alternative to 365 daily […]

Strides Pharma’s HIV generic drug gets tentative FDA approval

Strides Pharma’s HIV generic drug gets tentative FDA approval

Strides Pharma Science Limited (Strides) announced that its Singapore-based stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, has received tentative approval for Dolutegravir 50mg tablets from the United States Food & Drug Administration (FDA). The tentative approval, which deems the Dolutegravir 50mg tablets bioequivalent and therapeutically equivalent to Tivicay Tablets of ViiV Healthcare Company, […]

Aurobindo Pharma gets tentative FDA approval for generic HIV treatment for children

Aurobindo Pharma gets tentative FDA approval for generic HIV treatment for children

Aurobindo Pharma Limited has achieved a significant milestone by securing the US Food and Drug Administration (FDA)’s tentative nod under the PEPFAR program for its generic dispersible tablet, a fixed-dose combination of Abacavir 60mg, Lamivudine 30 mg, and Dolutegravir 5 mg (pALD). This formulation is pivotal for treating children afflicted with HIV, particularly those weighing […]

Lupin gains tentative FDA approval for Dolutegravir Tablets generic

Lupin gains tentative FDA approval for Dolutegravir Tablets generic

Indian pharmaceutical company Lupin announced that the US Food and Drug Administration (FDA) has granted tentative approval for its Abbreviated New Drug Application (ANDA) for Dolutegravir Tablets for Oral Suspension, 5 mg. This approval will allow Lupin to market a generic equivalent of ViiV Healthcare’s Tivicay PD Tablets for Oral Suspension, 5 mg. The tablets […]

ViiV Healthcare secures Cabenuva FDA approval for HIV-1 treatment

ViiV Healthcare secures Cabenuva FDA approval for HIV-1 treatment

Cabenuva FDA approval : ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its long-acting regimen Cabenuva for the treatment of HIV-1 infection in adult patients. According to ViiV Healthcare, Cabenuva is being given as a co-pack with a couple of injectable medicines that include the company’s integrase strand transfer […]

ViiV Healthcare bags Rukobia FDA approval for HIV patients with limited treatment options

ViiV Healthcare bags Rukobia FDA approval for HIV patients with limited treatment options

Rukobia FDA approval : ViiV Healthcare said that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets as a new treatment of HIV patients having limited treatment options. According to the FDA, Rukobia is a new type of antiretroviral medication for adult HIV patients who tried various HIV medications […]

ViiV Healthcare secures Dovato EMA approval for HIV-1 treatment

ViiV Healthcare secures Dovato EMA approval for HIV-1 treatment

Dovato EMA approval : The European Commission (EC) has approved ViiV Healthcare’s once-daily, single-pill, two-drug regimen Dovato (dolutegravir/lamivudine) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Dovato EMA approval The European approval for Dovato is for adults and adolescents aged over 12 years, weighing more than 40 kg, with no known or […]

FDA approves ViiV Healthcare’s Juluca for maintenance treatment of HIV-1

In the latest pharma industry news, ViiV Healthcare has bagged Juluca FDA approval for the maintenance treatment of virologically suppressed HIV-1 infection.

FDA approves ViiV Healthcare’s Juluca for maintenance treatment of HIV-1

ViiV Healthcare, a joint venture between GlaxoSmithKline (GSK), Pfizer, and Shionogi, has received approval from the U.S. Food and Drug Administration (FDA) for its two-drug regimen, Juluca, for the maintenance treatment of adults with virologically suppressed human immunodeficiency virus type 1 (HIV-1). This groundbreaking treatment, composed of dolutegravir 50mg and rilpivirine 25mg, is the first […]